- Earnings call transcript Q3 2022

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Operator

Greetings, and welcome to Chemomab's Third Quarter 2022 Earnings Conference Call. At this time, all participants are in a listen-only-mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Barbara Lindheim, Vice President of Strategic Communications. you. Thank

begin. may You

Barbara Lindheim

are Chemomab Executive attending. third Interim and Consulting I Communications our Chief Chief me of the CEO; and Chairman Thank Marvin, Co-Founder President; Don Vice conference David Dr. you Dr. CMO. Strategic CFO, today With Chemomab. for am Officer at Officer; Pfost, Therapeutics to Weiner, our quarter and and XXXX Operating call. President Dale Vice Welcome Scientific Barbara Mor, Lindheim, Adi

actual that on to differ over could from reliance statements statement. plan about of call cause may, our the please contain take statements, to we forward-looking forward-looking expressed and place turning Before and with expect, press be uncertainties similar that and are are forward-looking based as made our call. of review Dale, on words should issued today's words or undue Today's forward-looking risks management's forward-looking more intend, release note could, are operate. to discussion encouraged we materially will, filings subject cause factors not those such may results from earnings statements. expressions. those call materially our for that other the to identified today together which statements All may SEC differ by environment in business These our and expressed and statements complete or which could current in Listeners a our and beliefs actual on this results our to implied morning, expectations, implied assumptions

Form heading headings annual Risk list factors of comprehensive our any factors changing other date other XX-K, does the of Factors for on and events, Chemomab publicly and reports we information, new the as together in contained subsequent similar the future or materials filed with SEC. read the under reason. under report to can a forward-looking with undertake laws, to by securities federal circumstances You as update made a revise Except any not or statements required result those

the to Let now over turn Dale. me call

Dale Pfost

Chemomab to our of advances make will we conference quarter call. third third on fronts following cover quarter. since have Today, the I the pleased the report the Welcome I we achieved am call that continued multiple to last good to covering progress XXXX. during three

CM-XXX, First, we programs targets novel advanced disease CCL-XX, fibrosis in monoclonal the of our neutralizes confluence clinical antibody first for that class our inflammation. at and a

data severe hospitalized reduced lung from study Second, lung pneumonia. an with CM-XXX of that we showing COVID biomarkers patients clinical in fibrogenesis and unveiled promising injury investigator-initiated inflammation

scientific and Third, data new the programs. showing two we of primary used has strategic inform preclinical at development derisk biomarkers to tool in as our a major second, drug Chemomab and presented sclerosing of pathophysiology cholangitis, role meetings, CCL-XX how one the supporting

as make in biomarker summary, to been continue In ensure in weeks. reported We programs, coming fibrosis clinical our and will working liver David good CM-XXX have we Weiner in the Dr. that will discuss progress Phase II analyzed detail. our be data to greater

sclerosing primary clinical while trial to efforts our recruitment outreach or support cholangitis, Phase expanding required global filings and the in continue expansion. submitting II open new patient for trial our regulatory We to sites PSC, and

significantly cell relevant communities neutrophils initiated CCL-XX and our These study a were we CM-XXX these study SSC, role important in see educate to liver demonstrated we for systemic Phase from of that Chemomab the or of data trial role biomarkers lung about meetings. was designed the biomarkers the pathophysiology findings diseases, ongoing major across example systemic clinical support of researchers induced sclerosis, critical on of presented presentation planned pleased changes PSC. types recruitment activity will PSC. year. and a in used key to study are the hospitalized the good number fibroinflammatory in presentations of a Mor's testing of later fibrogenesis at have shortly. for At to well II we inflammatory sclerosis. CM-XXX scientific AASLD inflammation key of poster will important show that an with the tolerated Adi efforts meeting, investigator-initiated very characterizes that two the CCL-XX data of hope reporting in We of causing the Most role the models, see company in plays was that Adi players and of involvement. are also in damage of we in and biliary Diseases, made a have Association fibrosis monocytes COVID-XX Lastly, this activities. on data in serious patients and other that immune Liver CM-XXX discuss our the scientific and relevance that Dr. fibrotic start-up medical of trafficking In CCL-XX and to biomarker American be animal critical the reinforces indications migration Study with

of drug development. clinical Dr. We where CM-XXX with gave experiment them process inform throughout key validating our Boston at can migration as new the to neutralizing the discovery evidence, our growing are to target the a development how and and potential we CCL-XX a used model fibrotic biomarkers design PSC. showed in highlighting strategically was to tool Adi immune has speaker and the use translational trial how and cells use Chemomab biomarkers derisk of today. body featured she in and animal also inflammatory Summit CCL-XX study an presentation Development therapeutic CCL-XX-stimulated Anti-fibrotic drug continuing Drug confirming of show This And adds Mor for that interfere antibody. of the a yesterday, growing

the and over to CSO. Adi our turn Co-Founder now me call Mor, Let

Adi Mor

and clinical Conference International and Union study safety presented COVID-XX. Lung you, at I Thank I derived Dale. want lung share injury on activity clinical a with Conference from Health. Earlier new hospitalized this positive study Today, to assessing CM-XXX in patients data severe this week, the from

from release on available will be the website. press the study, a presentation the issued Chemomab also We on slides and the

X, the study and of and first corticosteroids objective the agents, baseline to a patients Chemomab enrolled respiratory oxygen. for similar of COVID-XX was hospitalized and are with to relevant supplemental fibrosis. X exposures initiated sclerosis. and following who The and diseases. involvement. Levy involving at drug styles treats to This previous Some administration. were in serum tolerated. followed similar well and were COVID-XX of Center and study ill its and in to inflammation of drug [ph] days single-arm of therapy, clinical systemic kilogram Clinical Professor on Medical are population CM-XXX was tested seen target X, was care be daily Yair were of impact XX related patients open-label on rheumatological lung biomarkers the during biomarkers in safety found All hospitalization single of severe the were what per antiviral including systemic underlying mechanisms XX CM-XXX. researchers to trial including seen chronic days. Israel, studies CM-XXX XX with Administration engagement patients rheumatologist, The severe resulting were the acutely were evaluate CM-XXX lung of have other safe with and day and in sclerosis patient dose lung also a pneumonia, receiving this study profiles XX-milligram activity tested patients those intravenous and inflammation infection from to with hospitalized treated Meir parameters inflammation All diseases that by in on COVID-XX

highly of in levels CM-XXX. reductions and included strongly to biomarkers rapid Reductions serum CXCLX CXCLXX, with neutrophil associated inflammation, and cytokines lung be Importantly, post-treatment observed inflammation respiratory serum in severity. of two and are the correlated that with with biomarkers lung are fibrogenesis activity biomarkers were known the

decreased as too of sustained It follow-up baseline post rapid patients CM-XXX robust further XX% treatment the reductions XX at at was marker general as c-reactive CRP, median XX% and stable by as reduced day a with end well-known For larger levels effect the standard control administration care clinical or rapid until Covid-XX of received CM-XXX almost change day after demonstrated soon noteworthy period. of follow-up a X. also CRP retrospective a reduction CM-XXX also XX% to the who and inflammation, example, by characteristics than in CXCLXX X XX-hours similar more as of remained demonstrated end were and soon reduced therapy. had hours CM-XXX through CRP was by further compared a post-administration. The median XX% of receiving of from that group period. the and protein, and was more

remained fibrosis reporting call for Interim that the disorders. were change highly until forward lung, in the a extracellular soon and formation elevated including biomarker fiber contribute that and CXM, and with and the Medical coming associated growing inflammation with rationale now the with conclusion, skin. of anti-fibrotic of tolerability that Officer. patients weeks These hours as to matrix, number a Procollagen with biomarker the the were of to expect extended liver suggesting post-treatment, which in patients. inflammation we these of Dave has study as a significantly therapeutic clinical as evidence CM-XXX effects the of CM-XXX degradation reduced liver data impacted XX turn will treatment also NASH demonstrating and We the understanding systemic confirmed to new and effects. of increase study In across body our this and further anti-inflammatory at our sclerosis data baseline in utility our by associated in believe these are CM-XXX's Lastly, drug. Moreover, supplementing Together, and Dr. and lung safety X strengthening profile look end reduction potential these we with the the TMXX for CM-XXX the of I clinically them a antifibrotic demonstrated median add XX% fibrosis, attenuate biomarkers will and this Weiner, supporting the such follow-up treating results period. organs further be we data Chief to to relevant in over the fibrogenesis to of inflammatory patients data the CM-XXX's changes anti-inflammatory and and stable lung potential encouraging clinical varied

David Weiner

status I patients of patients, focus brief providing in I sclerosis. will our sclerosing updates on and trial the Good primary design trial in cholangitis. fibrosis an in Phase on remarks of our will CM-XXX of CM-XXX our my Today, systemic Phase with the NASH trial overview of be morning. liver II providing II

working sharing community. systemic closely been have to and you with the and look with experts planned We study the sclerosis forward

administered begin steatohepatitis, randomized, CM-XXX placebo-controlled of the trial, kilogram per liver nonalcoholic in dose a trial with NASH. with or me Let evaluating subcutaneously at patients a fibrosis milligrams X

the trial this from data support that trial at We are program. sharing of on for in readout overall target look provide and that time. will a before forward insights the believe year-end CM-XXX data clinical final to the We development useful

of signs the hospitalized Phase patients we in encouraging and the small, study NAFLD a in makes is size activity saw will informative biomarker this sample of us CM-XXX week patients the activity Although the lung Ib in study optimistic study that in this reported results. COVID-XX produce injury

data CM-XXX's of liver these activity first disease. with represent Importantly, established the in readout patients

pharmacokinetic noted to formulation previously, believe subcutaneous provide of the the us CM-XXX. next we the our in of should also results study steps As current data inform tolerability I've needed the development and

Turning trial. to our Phase II primary cholangitis sclerosing

recruit in clinical and actively patients the U.S., to Israel. continue We Europe sites trial across

needed are trial a label advancing the submissions trial dosing. and open major adding expansion for supporting and protocol We amendment are implementation additional of sites regulatory

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higher currently safety to CM-XXX the to program. year. kilogram of the monitoring the XX interim safety primary development completed enable the clinical Lastly, the of and expect this evaluation dose committee by analysis cohort before enrolling will to an in CM-XXX performing milligram the purpose is review dose end The analysis support the we be be per analysis data this of of

is Turning a Today, tissues. sclerosis. in therapeutic disease, a disease recent in the fibrotic a clear various the need remains lung patients, providing are interstitial particularly to characterized the dermatologic that multiple of this rheumatologic represent in of slow there treatment systemic pathophysiology of medical manifestations a progression the novel major unmet in SSC. that our address advance approvals SSC planned therapies clinical of SSC. disorder SSC Despite by an can sclerosis aspects could inflammatory disorder, systemic would in we complex overview trial or and of

rare based We appropriate well levels we of CCL-XX SSC the therapeutic to lines for evaluations and in respond skin, that and for identify genetic in be patients, vasculature CCL-XX pulmonary the rodents deletion CCL-XX convergent lung can this this relevant to patients and patient who disease. are neutralization developing the data study CCL-XX evidence, translational of for critical disease enrich of includes a generate study initiating SSC chemokine. SSC target expression correlated of the data with demonstration CCL-XX clinical This in In multiple as to with a clinical that This and to greater optimal demonstration our CM-XXX, biological that confirm we selection CCL-XX within lung, including seek in that CM-XXX. inform rationale trials. subsequent a physiology manifestations strong role higher CCL-XX SSC SSC are disease. attenuates more this levels designed have the on rationale patients will population of in and of to may, with with to of likelihood in this critical To to in the likely have high bleomycin serum trial of is and skin suggesting model challenge endpoints us of patients establish levels of as of neutralization higher proof-of-concept of these end, that and enable disease therefore, of and

placebo-controlled the study cutaneous double-blind study XX will treatment, X limited XX Of eligible will be and enroll patients active disease. with to manifest cutaneous XX intravenous those To for milligrams to XX-week either patients The and infusion via We approximately period double-blinded, with characteristics, a XX patients placebo. and manifestations be SSC. will be will the randomized diffuse at includes will disease. treatment disease, will randomized, X patients the half CCL-XX. to key will with be with also patients study treatment and clinically that active patients trial or CM-XXX half The receive limited pulmonary have study, patients of XX a presence serum high CM-XXX must active the on kilogram of of of dermatologic assigned levels have circulating SSC randomized during will a dose every which per weeks. diffuse

period, enrolled infusion skin, CM-XXX per kilogram will Following skin a double-blind where the double-blind treatment patients period, will period. open-label primary changes will patients XX trial the receive vascular tolerability treatment with All patients from the of period, dose all XX-week will undergo weeks. and of safety enter treatment X the milligrams as baseline multiple biopsy of measure at a CM-XXX. treatment the to principally All The intravenous along and every a outcome the clinical and with of via be pulmonary at for assessed double-blind demonstration again after outcome of measures other end be assessments baseline function. will

Pharmacokinetics readouts. are biological not pulmonary-related to inflammatory burden assessments in European outcome vascular and manifestations States, the relevant also of for associated and Exploratory including study using evaluate limited focused but be MMPs ex disease assay. factor-related as using We study. biological as CCLXX, biomarkers, function enable and IL-X scores. multiple lastly, informative reporting include immune biological of markers CRIP biological this and Exploratory evaluation Rodnan capillaroscopy, cell using markers fibrogenesis the and to and such function collected biomarkers, that skin collagens, VEGF and and levels. target serum-based such antibodies secondary The known revised are outcome neutrophil CCL-XX and KLXSPD PDGF, and fibrotic and secondary involvement Vascular different such should engagement scale. with in of highly will to we expression and vivo and expression Inflammatory, as at the us biopsies, will including CM-XXX, trial extracellular measures CCRX and Israel. These conduct The any of biomarkers, such include the KL-X, ELF imaging SSC, matrix evaluation and will to antidrug during target as ultra of of on modified clinical Union multiple pulmonary outcome the vascular multiple CCLX, on cytokines, growth CXCLXX. using the intend presence assessments United scoring, include pulmonary intervention sites involvement of monitor with tests the outcomes phenotyping, effects and potential nailfold involvement, data patient in global CM-XXX outcomes measures. digital

we Drug XXXX, the file for Officer the of new XXXX. QX Chief trial and year in Don this coming With open data line we documents, by be available the that the second Food I will anticipate Vice top or Executive currently call regulatory an Operating of U.S. the early Financial that, weeks. investigational intend required and of to drug to in and turn trial will Don? and will President. that for with We finalizing application the end enrollment the Administration are the our anticipate in Chief the half Officer, readouts be over We Marvin,

Don Marvin

day. Good

CFO Chemomab, to third more see of highlights detail. the morning to stakeholders. XXXX this release directly communicate review our financial shareholders have pleased this for and with quarter issued performance. Today, we am press As Please of I our will I opportunity other

our again for can ensure market As for to focusing from CM-XXX, what distracted to very is not we as We are challenges. markets, and resources opportunities successful rigorous to for job are company. And development attractive on ensure do clinical the advancing biotech remains pursuing the forward. Chemomab, you we goals, our a we ecosystem the programs capital note additional fashion know, that optimal conserving strive prudently in-house tracking for path competitive are and extent bring on and monitoring good build believe finances, we cannot potential challenging. permit to change need we that while assets stocks want I doing so a going to as possible these delivering and do feasible, we the for our that to while as to managing we will

was to increases and approximately related of increases to management of salaries mainly quarter weighted share related additions XXXX September XX.X number net share XX, a same $X.X ended outstanding, as expenses for expense cash shares September quarter Net expenses The ADSs the due $X.X were million summary bank of $X.XXX for compared XX, our $X.X $XX.X $X.X the key diluted compared ordinary as same increase Cash, were of performance basic average to the XXX,XXX,XXX loss the to for now support and ordinary for at me share increase expenses in ended the to of in compared as deposits diluted per financial million million quarter September a basic approximately million XXXX XXXX. the and quarter and XXXX. XX, Let were activities XXXX XX, or $X XXXX. share-based June for ended equivalents of September compared The or R&D senior a programs. million to in primarily and benefits million the million in $X.XXX equal were XXXX. our XXXX. of XXXX. in for quarter preclinical primarily quarter $XX.X diluted ordinary XX, third for R&D approximately reflects September million to increase year-over-year in ended third team, and The in the noncash clinical basic for well XXXX $X.X loss per net was loss the quarter million XX, expenses. the quarter to of G&A

our to and with XXXX, to runway continue us the would appreciate support of manage as you I Dale. to We will out indicated continuing Dale? now We back call through in call. expect our you your to last invite if last reach we prudently to the and our turn currently like directly. cash end communicate

Dale Pfost

launching and the some treated. trial. liver fibrosis are to forward to our accelerate look Chemomab. momentum our we our in we expand the building are to and poorly so Hope results at of We continuing coming innovative trial systemic PSC excitement biomarker sclerosis These conveyed our about to have diseases the sharing trial debilitating currently of weeks

continued make to We the Stay patients. open at are the optimistic We do that the to of and the a we the and of modify unique are disorders progression has support. to potential dual tuned. to fibrosis inflammation confluence of appreciate real questions. Operator, floor for these ready CM-XXX difference mechanism your

Operator

Thank you.

Kristen your will Kluska We now with session. Instructions] Please [Operator with Our question-and-answer first conducting Fitzgerald. Cantor a from be question. question proceed is

Kristen Kluska

Thanks Hi, afternoon, And everybody. question. good morning. for my good taking

patient to preclinically, I you that of could CCL-XX enroll? SSC, has severity. these that correlation of you've know talk the on then levels the percent about hoping and a population higher to overall shown that levels First And you're disease CCL-XX

be So spectrum? should more these the to we on moderate be severe expecting to disease patients

Dale Pfost

that Dave, want then to with pass it start do you I'll maybe to and Adi.

David Weiner

are the out to what currently do in like population. mapping happy Kristen. not actually sclerosis morning, that. across Yeah, The we intent impair Good Yes, levels systemic trial the is enrollment. look to CCL-XX

about XX%, we'll within levels sclerosis screen. systemic greater with roughly as enroll probably those XX% tile we So or

so knowledge intend deep where very approaching of it exclude that Adi? exact this deep cut-offs are a a levels. And without - with experimental cytokine those for to understanding perspective from very we're essentially we particular low practical population, what in and

Adi Mor

Yes. you. Thank

vascular-related add we as said as that thank the in for several you can one past CCL-XX ELF. just indeed, systemic manifestations well your Kristen, sclerosis, I pulmonary, to correlate So and some digital that, biomarkers question, that and like fibrotic-related or measurements second with of have is

and chance this ones do the in more overall - that better patients So determined different with terms a provide the success the in see will will of cut-off with that spaces. be are it more CCL-XX enrolling the we active – for that population relevant or believe

Kristen Kluska

that any might extensive without And some necessarily these Thank of of that. for correlate levels obvious you higher of with are aware conducting tests. CCL-XX you items

different like have having Or and are of fibrotic you symptomology So for I related noted of more to levels? both role are example, reflective CCL-XX markers that know conditions. any perhaps, it coming has inflammatory differences different But certain the geographies? patients from in there from these a

Dale Pfost

you want one? take Adi, that do to

Adi Mor

sure. Yeah,

and about their So with correlations manifestation predictive deterioration related see lung why across baseline ELF also disease. more geographies, a of this higher But XX for the CCL that we're We seen CCL-XX definitely more [ph] have the lot [ph] between patients but with did function, we and had of seen vascular have and their a we've alter as the part digital this overall decided correlations an parameter seeing criteria. include we inclusion data is far what on of to so

Kristen Kluska

Okay. question Thanks. for And me. last maybe

had last the from of of heard You've number scientific love a Would scientific some over hear you've here. couple days presentations the to feedback of the community?

Dale Pfost

Adi?

Adi Mor

sure. Yeah,

with the with actually, great where derived study in sclerosis. fibrosis. earlier, to of of in patients and systemic COVID-XX. and I field So lung just physicians the yesterday to of CM-XXX all inflammation share specifically due that injury was like similarities presented Union and CM-XXX it's dose day and great single FDD the an And at And also lung I a into presented researchers we between other of administration obviously, that that know the COVID-XX some in chronic Boston the audience presented a diseases have clearly seen opportunity we injury a the conference

Operator

Okay.

question proceed next Oppenheimer. your Jones with with comes Our question. Jeff from Please

Jeff Jones

And differentiate the line blind And population you PSC questions. for port following or mg I those there populations the Good be at just cohort? blinded perhaps patient a related to per kg discussion. or XX biomarker question. data you're portion thanks discriminately on as of thought afternoon, evaluate inflammatory responders study using you interim guys, [ph] to therapy? it's looked Have the where elevation if taking of indicated you've from the sitting. driver saying is guess, our believe One, top on XX I that morning Is two if the to biomarkers, I Thanks. or are state result though more side, on on a in to guess the a who to original good depending then as XH data CCL-XX way the the the any to given likely reporting

Dale Pfost

pick one first? to want you do second Dave, the up

David Weiner

Sure. option we enroll recent Happy we to that the you as cohort trial an is is surmise than expansion. all we Jeff. certainly the term that – include, Yes, nearer Good cohorts that make that the can That - we amendment to a than that. consideration added since do likely the particularly and full is morning, additional through in have.

study in the and the position study. run study, we And hope sense. that the to it it that think this regulatorily a our as about like we As protect such, is longer in be supportive could would

so that study weighing, it's the data outcome. for are is, those that any do although an look when us an option interim to earlier And decision, [indiscernible] things we're you the two on an particular at versus power analysis

there hear to more our unfolds. think I trial as So

Jeff Jones

I also have a...

David Weiner

to question happy I'm Yes. return... start on the second then if do I

Adi Mor

you can if hear am here, me. I

David Weiner

wonderful. Great, Okay.

try to And a and have exploring, trial exactly our - looking early right? do CCL-XX levels clearly, you've the CCL-XX. encouraging our clinical see her is for the antibody at data asked us population enrich target, exploring that are And to right? for that Adi this patients the This The many have looking and colleagues strategy to and quite the different motivation outcomes? that straightforwardly. retrospectively the we're biologically mechanism with to, here neutralizes at in elevated or do we biomarkers is to patient what they those levels very either exactly and populations through question relevance to high to with to very here, the that trying been study either correlate the is respect that questions ones of or On there. ask is people how of of So this

from trial, outcomes. clinical levels the to ask trial patients, that would we'll levels which is effect group the of size is We'll relationship is or going the and with. the in neutralizing and between given itself So understand asking, actual - have whether insight I a that greater think those biomarkers higher in question that get also the what higher does to you're begin

strategy that's part Adi? there. the So of

Adi Mor

covered you think I that Yeah, very well.

of with is is kind preclinically, disease, it's the in sclerosis cause of cycle. familiar of the and obviously of we asking, [ph] or CCL-XX Jeff, inflammation cycle cause were perpetuating for and the kind we're And involved not this the PC if have seen what fibrosis. systemic part of You but vicious

the by if is further was genetic vicious kind our or reason, of even expression by an CCL-XX kind this of injury found the disease So its models progress cycle to kind some environmental alone/ in of

Jeff Jones

appreciate guys. insight. that I Great. Thanks,

Dale Pfost

Thank you.

Operator

It no time. [Operator that this are there at Instructions] questions appears Okay. further

the turn So floor I like would to closing now over for back comments. to management

Dale Pfost

interest months and questions Chemomab your to much. further I forward programs and you making ahead. Thank for in great our believe updates are and today. progress, very look in the you thank Well, we team

Operator

today's concludes This teleconference.

You your time. lines at Thank disconnect participation. you your may this for

Chemomab Therapeutics (CMMB) 11 Nov 222022 Q3 Earnings call transcript